Regulatory PathRegulatory requirements compared

Active substance

Diclofenac epolamine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
FLECTOR EP GRANULES65 mgGranules · Oral use20 SachetSAR 40.00NCE · PrescriptionIBSA INSTITUTE BIOCHIMIQUE S.AValid
FLECTOR EP TISSUGEL 1GM PATCHES13-10 mgMedicated plaster · Topical5 PatchSAR 49.35NCE · OTCIBSA INSTITUTE BIOCHIMIQUE S.AValid
Indications — CHI Daman Drug Formulary

ACUTE PANCREATITIS-PAIN MANAGEMENT; ANKYLOSING SPONDYLITIS; BACTERIAL TONSILLOPHARYNGITIS TREATMENT AND PREVENTION; CHRONIC PANCREATITIS; DENTAL ABSCESS-DENTAL PAIN; ENDOMETRIOSIS; EPIDERMOLYSIS BULLOSA; INFLUENZA-SYMPTOMATIC TREATMENT; LOW BACK PAIN; MENSTRUAL DISORDERS; MIGRAINE/ HEADACHE; MUCOSAL ULCERATION-SUPPORTIVE AGENTS; NON-INFECTIOUS UVEITIS; PAIN MANAGEMENT IN CANCER PATIENTS; PERICORONITIS; POSTOPERATIVE PAIN; RENAL AND URETERIC STONES; RHEUMATOID ARITHRITIS

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
FLECTOR1.3%system · topicalIBSAPrescription31 Jan 2007
LICART1.3%system · topicalIBSA INST BIOPrescription19 Dec 2018

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACDICLOFENAC EPOLAMINE 1.3% PTCH$4.70708per EA23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

  • US FDA 27 Mar 2026 LICART — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 21 Nov 2024 FLECTOR — safety-related labeling change
    Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for diclofenac epolamine →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.